Energy-Harvesting Mesofluidic Impulse Prosthesis: e-MIP

Evaluation of an Energy-Harvesting Mesofluidic Impulse Prosthesis (e-MIP) in Transtibial Prosthesis Users

The purpose of this research is to validate the e-MIP design and function by testing the ability of e-MIP to harvest energy and return a sufficient amount of energy to assist the user during gait. The investigators will also evaluate whether prosthetic users are able to wear and use the e-MIP device long-term.

Study Overview

• Status: Withdrawn
• Conditions: Transtibial Amputation; Artificial Limbs
• Intervention / Treatment: Device: Habitual Prosthesis; Device: Energy-Harvesting Mesofluidic Impulse Prosthesis

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David Boone, PhD; Phone Number: 1004 425-771-0797; Email: dboone@orthocareinnovations.com

Study Locations

• United States
  • Washington
    • Edmonds, Washington, United States, 98020
      • Orthocare Innovations, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Unilateral transtibial amputation
• At least twelve months post-amputation
• Currently walking on a prosthesis for at least one year
• Uses modular endoskeletal prosthetic components
• Has bilateral normal range of motion
• Ability to walk independently and for an extended length of time (walking ability of each individual will be assessed by the principal investigator or study prosthetist during the recruitment period)
• Ability to communicate individual perceptions
• Ability to provide informed consent

Exclusion Criteria:

• Confounding injury or musculoskeletal problem
• Pregnancy
• Lower limb peripheral neuropathy
• Symptomatic cardiovascular disease or chronic obstructive pulmonary disease
• Not able to read and understand English

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Habitual Prosthesis; Participant's existing baseline prescribed prosthesis	Device: Habitual Prosthesis; Habitual baseline prosthesis prescribed by participant's clinician.
Experimental: e-MIP; Experimental ankle-foot prosthesis	Device: Energy-Harvesting Mesofluidic Impulse Prosthesis; e-MIP is an experimental lower limb ankle-foot prosthesis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Energy returned	The amount of energy returned at the ankle joint, calculated from ankle torque and angle sensors with respect to time.	After four weeks with Habitual Prosthesis
Energy returned	The amount of energy returned at the ankle joint, calculated from ankle torque and angle sensors with respect to time.	After four weeks with e-MIP (system ON and system OFF)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Steps	The number of steps taken by the participant will be recorded over four weeks with a step activity monitor.	After four weeks with Habitual Prosthesis
Total Steps	The number of steps taken by the participant will be recorded over four weeks with a step activity monitor.	After four weeks with e-MIP (system ON and system OFF)
Step Rate	The speed of steps taken by the participant will be recorded over four weeks with a step activity monitor.	After four weeks with Habitual Prosthesis
Step Rate	The speed of steps taken by the participant will be recorded over four weeks with a step activity monitor.	After four weeks with e-MIP (system ON and system OFF)
Step Activity	The number of continuous steps taken by the participant will be recorded over four weeks with a step activity monitor.	After four weeks with Habitual Prosthesis
Step Activity	The number of continuous steps taken by the participant will be recorded over four weeks with a step activity monitor.	After four weeks with e-MIP (system ON and system OFF)
Prosthesis Evaluation Questionnaire	Responses to the psychometrically validated scales of the Prosthesis Evaluation Questionnaire for persons with limb loss, in order to understand the participant's perception of the prosthesis. Questionnaire scores range from 0 to 100. Higher scores indicate a better outcome.	After four weeks with Habitual Prosthesis
Prosthesis Evaluation Questionnaire	Responses to the psychometrically validated scales of the Prosthesis Evaluation Questionnaire for persons with limb loss, in order to understand the participant's perception of the prosthesis. Questionnaire scores range from 0 to 100. Higher scores indicate a better outcome.	After four weeks with e-MIP (system ON and system OFF)
Spatio-Temporal Gait Parameters	The spatio-temporal parameters of gait, such as walking speed, will be measured using motion analysis.	After four weeks with Habitual Prosthesis
Spatio-Temporal Gait Parameters	The spatio-temporal parameters of gait, such as walking speed, will be measured using motion analysis.	After four weeks with e-MIP (system ON and system OFF)
Kinematics during Gait	Kinematics such as hip, knee, and ankle joint angles will be measured using motion analysis.	After four weeks with Habitual Prosthesis
Kinematics during Gait	Kinematics such as hip, knee, and ankle joint angles will be measured using motion analysis.	After four weeks with e-MIP (system ON and system OFF)
Kinetics during Gait	Kinetics such as hip, knee, and ankle joint torques will be measured using motion analysis.	After four weeks with Habitual Prosthesis
Kinetics during Gait	Kinetics such as hip, knee, and ankle joint torques will be measured using motion analysis.	After four weeks with e-MIP (system ON and system OFF)

Collaborators and Investigators

• Sponsor: Orthocare Innovations, LLC
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2019
• Primary Completion (Actual): July 10, 2022
• Study Completion (Actual): July 10, 2022

Study Registration Dates

• First Submitted: October 31, 2019
• First Submitted That Met QC Criteria: November 6, 2019
• First Posted (Actual): November 8, 2019

Study Record Updates

• Last Update Posted (Estimated): October 10, 2023
• Last Update Submitted That Met QC Criteria: October 6, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 0309-02; 2R44HD080309 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes